FOR UK NURSING MEDIA Embargoed until: 00:01 GMT, Friday 13 March 2015

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1 Contact: Ross Selby Takeda UK Ltd News Release FOR UK NURSING MEDIA Embargoed until: 00:01 GMT, Friday 13 March 2015 World s first gut-selective treatment for ulcerative colitis made available to UK patients NICE says Yes to Entyvio (vedolizumab) in final ruling 1 NICE recognises innovation of first-in-class vedolizumab as a step change in treatment 1 Vedolizumab provides cost effective, long-term remission from symptoms and improves quality of life 1,2 Unlike other treatments, vedolizumab selectively targets the immune system in the gut, so the rest of the body s immune system remains unaffected; it has similar side-effects to placebo 1,3,4 Current treatments do not work for all patients, can stop working over time and some have serious safety concerns 5,6,7-78% of emergency surgical admissions result from failure of medical therapy 8 IBD nurses will play a key role in identifying suitable patients and administering infusions UNITED KINGDOM, Friday 13 March 2015 The National Institute for Health and Care Excellence (NICE) has today recommended vedolizumab (Entyvio) in final draft guidance for use on the NHS for adults with moderately to severely active ulcerative colitis (UC) across its full licenced indication. 1* NICE has recognised that vedolizumab is an innovative, cost effective option, which represents a step change in treatment because of its novel mode of action, 1 providing long-term remission from symptoms and improved quality of life with a safety profile similar to placebo. 1,2,4 Inflammatory bowel disease (IBD) nurses play a vital role within the care team, providing patient support and contributing to treatment decisions. A recent UK IBD nurse audit found that one-third of nurses are independent prescribers and more than half directly influence treatment decisions. 9 IBD nurses will play a key role in identifying appropriate patients for treatment with vedolizumab and administering infusions. Dr Karen Kemp, IBD Nurse Practitioner, Manchester Royal Infirmary, commented, This is the first new class of treatment in over a decade and the data is very exciting, as it provides a real step change in treatment. Vedolizumab is an important new treatment for our patients living with this lifelong condition. Vedolizumab is a 30-minute intravenous infusion given every eight weeks after induction. 3 It works selectively in the gut to help block the entry of white blood cells, 3 reducing inflammation and associated Job code: UK/EYV/1503/0043a *The full licence indication is on page three Date of preparation: March 2015

2 symptoms, 4 such as urgent and frequent bloody diarrhoea, rectal bleeding and extreme fatigue. 10 These distressing symptoms can leave people house-bound, having a profound impact on everyday life. 11 For most UC patients, the primary objective is to resolve symptoms as quickly as possible and avoid relapses and side effects. 12 Efficacy - In clinical trials, 47% of people responded to vedolizumab within six weeks. 4 Of those patients that responded, 42% were in remission at one year compared to 16% on baseline therapies and placebo. 4 73% of vedolizumab-treated patients who completed the main one year trial remained in remission at year two (the extension trial). 2 Health-related quality of life was measured in the clinical trials at weeks 6, 30 and 52. Improvements in quality of life were greater with vedolizumab than placebo at all time points. 1 Safety - Current UC treatments come with serious safety concerns (including serious infections and cancer) because they suppress the body s entire immune system. 13 Vedolizumab selectively targets the immune system in the gut, so the rest of the body s immune system remains unaffected. 1,3 In clinical trials, the frequency of side-effects with vedolizumab was similar to placebo. 4 NICE recognised this difference as a step change in the management of UC. 1 Dosing - Vedolizumab has one dose for all patients, with no weight based adjustments. A 30-minute, single vial infusion (300mg) is given every eight weeks after induction. 3 Three UK centres (Barts and the London NHS Trust, Cambridge University Hospitals NHS Foundation Trust and University Hospital of Wales, Cardiff) were involved in clinical trials of vedolizumab. The final decision from NICE is contingent upon Takeda UK providing vedolizumab to the NHS within the terms of an agreed patient access scheme. 1 ENDS Notes to editors ABOUT ULCERATIVE COLITIS IN THE UK UC is a life-long condition characterised by chronic inflammation of the large intestine (colon). 11 It affects 146,000 people in the UK, 11 23,000 of which are under It is a relapsing condition, usually diagnosed in the late teens or early twenties and often leaves young adults dealing with unpredictable, debilitating symptoms when they are studying, finding their first job and establishing their adult lives. 10 The UK has the highest incidence of UC in the EU5 (France, Germany, Italy, Spain, UK) 15 and inflammatory bowel disease (UC and Crohn s Disease) costs the NHS 470 million per year. 10 Current treatments include

3 corticosteroids, 5-aminosalicylates, immunosuppressants and anti-tnfα biologics. 16 While effective in some people, these treatments do not work for all patients and can stop working over time: 40% of people fail to respond to biologic therapy and of those that do, 40% lose response over time 5 Anti-TNF adalimumab has a 72% failure rate for maintaining remission at two years in UC 5 UK hospital admissions and surgery rates remain high as many medical treatments fail to achieve long-term remission from symptoms. 8 78% of emergency surgical admissions for UC in 2013 resulted from failure of medical therapy. 8 Up to one third of patients will undergo surgery to remove their colon, 10 which can result in physical and psychological problems including sexual dysfunction, female infertility and infections. 17 ABOUT VEDOLIZUMAB (visit Vedolizumab is licensed for the treatment of adults ( 18 years old) with moderately to severely active UC and adults ( 18 years old) with moderately to severely active Crohns Disease (CD) who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or an anti-tnfα biologic. 3 Vedolizumab works by binding exclusively to the α4β7 integrin which is expressed on a sub-group of lymphocytes (a type of white blood cell) that bind to the MAdCam-1 receptor, expressed preferentially in the gut. 3 By blocking the α4β7 integrin, vedolizumab selectively reduces the influx of inflammatory cells to the gut. 3 In clinical trials in adults with moderately to severely active UC and CD, vedolizumab was generally well tolerated and showed statistically significantly better efficacy compared to placebo across a range of endpoints. 4,18 The safety and efficacy of vedolizumab was evaluated in the GEMINI TM Studies, the largest Phase 3 clinical trial programme to date evaluating both UC and CD patients in parallel. 19,20,21 In UC studies, vedolizumab has been shown to induce clinical response, remission and mucosal healing in patients with no prior anti-tnfα biological therapy exposure, as well as in those who have not responded or become intolerant to anti-tnfα therapy. 4 In CD studies, vedolizumab has been shown to induce clinical remission and to produce an enhanced clinical response and a corticosteroid-free clinical remission (at week 52) in patients with no prior anti-tnfα biological therapy exposure, as well as in those who have not responded or become intolerant to prior anti-tnfα therapy. 18 The most common side-effects were nausea, nasopharyngitis (common cold), upper respiratory tract infection, arthralgia (joint pain), pyrexia (fever), fatigue, headache, cough and infusion-related reactions. 4,18 As with other biologic treatments, there is an increased risk of infection and patients should be issued with a Patient Alert Card. 3

4 ABOUT TAKEDA PHARMACEUTICAL COMPANY LIMITED Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for people worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, ABOUT TAKEDA UK LIMITED Takeda UK Limited, based at High Wycombe in Buckinghamshire, is the UK affiliate of Takeda Pharmaceutical Company responsible for sales and marketing of the company's products in the UK. More information about Takeda in the UK is available at CONTACTS Siân Hurst, Director, Aurora Healthcare Communications Tel: +44(0) sian.hurst@auroracomms.com Chris Hall, Account Manager, Aurora Healthcare Communications Tel: +44(0) chris.hall@auroracomms.com Ross Selby, Market Access Director, Takeda UK Ltd ross.selby@takeda.com References 1 National Institute for Health and Care Excellence final appraisal determination Vedolizumab for treating moderately to severely active ulcerative colitis. March Feagan BG et al. Long Term Efficacy of Vedolizumab Therapy for Patients With Ulcerative Colitis. The American journal of gastroenterology 2014; 109:S473 S527 3 Entyvio Summary of Product Characteristics. June Last accessed March Feagan BG, et al. Vedolizumab as Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2013;369: Gilroy L, Allen P. Is there a role for vedolizumab in the treatment of ulcerative colitis and Crohn s disease? Clin Exp Gastroenterol. 2014;7: Garud S, Peppercorn MA. Ulcerative colitis: current treatment strategies and future prospects. Therap Adv Gastroenterol 2009; 2: de Jong DJ, Goullet M, Naber TH. Side effects of azathioprine in patients with Crohn's disease. Eur J Gastroenterol Hepatol 2004; 16: National clinical audit of inpatient care for adults with ulcerative colitis. UK inflammatory bowel disease (IBD) audit. Library/NCAPOP /AdultIBDInpatientCareAuditWeb 17Jun2014.pdf Published June Royal College of Nursing. Inflammatory bowel disease nursing. data/assets/pdf_file/0008/433736/ pdf. 10 IBD Standards Group. Standards for the Healthcare of People who have Inflammatory Bowel Disease (IBD).

5 11 NHS Choices. Ulcerative colitis overview. colitis/pages/introduction.aspx. 12 Kemp K and Sephton M. Aligning oral mesalazine treatment to health service priorities: guidance for nurses. Frontline Gastroenterology 2014;5: EMA Assessment report Entyvio. _Public_assessment_report/human/002782/WC pdf March CSD patient data, Cegedim Strategic Data UK Ltd [MAT June 2014] Ulcerative Colitis & Crohn s Disease Report 18 (TAK26763U_18). June Burisch J, et al. Curr Opin Gastroenterol. 2013;29: Talley NJ, et al. Am J Gastroenterol. 2011;106:S2 S25 16 NHS Choices. Ulcerative colitis treatment. colitis/pages/treatment.aspx. 17 Crohn's and Colitis UK. Surgery for Ulcerative Colitis (UC). Sheets/surgery forulcerative colitis.pdf 18 Sandborn WJ, et al. Vedolizumab as Induction and Maintenance Therapy for Crohn s Disease. N Engl J Med 2013;369: Electronic Medicines Compendium. Remicade. Last Updated July 10, Electronic Medicines Compendium. Humira. Last Updated May 07, Takeda. Data on file. Vedolizumab Integrated Summary of Safety